Form 8-K

8-K — Rafael Holdings, Inc.

Accession: 0001213900-26-067083

Filed: 2026-06-10

Period: 2026-06-10

CIK: 0001713863

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0294151-8k_rafael.htm (Primary)

EX-99.1 — PRESS RELEASE, DATED JUNE 10, 2026 (ea029415101ex99-1.htm)

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8-K — CURRENT REPORT

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities

Exchange Act of 1934

Date of Report (Date of earliest event reported):

June 10, 2026

RAFAEL HOLDINGS, INC.

(Exact name of registrant as specified in its

charter)

Delaware

1-38411

82-2296593

(State or other jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

520 Broad Street

Newark, New Jersey

07102

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including

area code: 212 658-1450

Not Applicable

(Former name or former address, if changed since

last report.)

Check the appropriate box below if the Form 8-K filing is intended

to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.

below):

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant

is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the

Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check

mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting

standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Securities registered pursuant to Section 12(b)-2 of the Exchange Act:

Title of each class

Trading Symbol

Name of each exchange on which

registered

Class B common stock, par value $0.01 per share

RFL

New York Stock Exchange

Item 7.01. Regulation

On June 10, 2026, Rafael Holdings, Inc. (the “Company”)

distributed over a wire service and posted the attached press release (the “Release”) to the investors page of the Company’s

website (www.rafaelholdings.com) announcing that the last patient has completed the final 96-week study visit in the pivotal Phase

3 TransportNPC™ study evaluating Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C.

In addition, the Company announced that Topline data from the main study cohort is expected to be announced in the second half of 2026.

A copy of the Release is furnished herewith as Exhibit 99.1 and is

incorporated herein by reference.

The Company is furnishing the information

contained in this Report, including Exhibit 99.1, pursuant to Item 2.02 of Form 8-K promulgated by the Securities and Exchange

Commission (the “SEC”). This information shall not be deemed to be “filed” with the SEC or incorporated by

reference into any other filing with the SEC unless otherwise expressly stated in such filing. In addition, this Report and the

press release contain statements intended as “forward-looking statements” that are subject to the cautionary statements

about forward-looking statements set forth in the press release.

Item 8.01. Other Events.

The information contained in Item 7.01 above is

incorporated herein by reference into this Item 8.01.

Item 9.01 Financial Statements and Exhibits.

(d)

Exhibits.

Exhibit No.

Document

99.1

Press Release, dated June 10, 2026.

104

Cover Page Interactive Data File, formatted in Inline XBRL document.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act

of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

RAFAEL HOLDINGS, INC.

By:

/s/ David Polinsky

Name:

David Polinsky

Title:

Chief Financial Officer

Dated: June 10, 2026

EXHIBIT INDEX

Exhibit Number

Document

99.1

Press Release, dated June 10, 2026.

104

Cover Page Interactive Data File, formatted in

Inline XBRL document.

EX-99.1 — PRESS RELEASE, DATED JUNE 10, 2026

EX-99.1

Filename: ea029415101ex99-1.htm · Sequence: 2

Exhibit 99.1

Rafael Holdings Announces Completion of Last

Patient Last Visit for Pivotal

Phase 3 TransportNPC™ Study

Evaluating Trappsol® Cyclo™ for the Treatment of

Niemann-Pick Disease

Type C

Topline

results are expected to be announced in second half of calendar 2026

The company has had a pre-NDA meeting with the

FDA and expects to submit an NDA in second half of calendar 2026

The company has received acknowledgement from

the FDA that our US Expanded Access Program (EAP) can proceed

NEWARK, NJ –June 10, 2026 (GLOBE NEWSWIRE)

- Rafael Holdings, Inc. (NYSE: RFL) today announced the last patient has completed the final 96-week study visit in the pivotal Phase

3 TransportNPC™ study evaluating Trappsol®

Cyclo™ for the treatment of Niemann-Pick Disease Type C (NPC). With 94 patients studied across

27 sites in 13 countries, the TransportNPC™ study is the most comprehensive, controlled pivotal study regarding patient size, global

footprint, duration and clinical outcomes of an investigational therapy for NPC. Additionally, 10 patients were enrolled in a single-arm

sub-study per the adopted Pediatric Investigational Plan (PIP) treating newborns to 3 years of age. Topline data from the main

study cohort is expected to be known and announced in the second half of calendar 2026.

Data presented

at WORLDSymposium 2026 from the single arm pediatric sub-study in patients ages zero to three, continues to highlight the potential

for Trappsol® Cyclo™ as a therapeutic option in NPC with 80% of the sub-study patients’ CGI scores showing

improvements or remaining stable with no serious adverse events considered to be related to the study drug.

“Reaching

the conclusion of the pivotal Phase 3 TransportNPC™ trial is a monumental achievement that belongs, first and foremost, to the patients

and families, advocacy organizations, and physicians who stood at the heart of this global effort. Together, we have advanced the clinical

understanding of NPC, as well as the lived experience of this devastating disease, as we work to deliver a potentially life changing treatment

option for a community with significant unmet need,” said Joshua Fine, Chief Operating Officer of Rafael Holdings. “We would

also like to recognize the FDA for their long-term continued collaboration, engagement and guidance in advancing this program.”

“Having

already completed our pre-NDA meeting with the FDA, we believe we have a clear, and expedited path forward reflective of the urgency

and unmet need in NPC and expect to submit our NDA in the second half of 2026. NPC represents a high-unmet-need market, positioning

Rafael Holdings to potentially unlock substantial, long-term value for our shareholders as we work toward transitioning Rafael

Holdings into a commercial-stage biotechnology company,” said Howard Jonas, Chief Executive Officer, Executive Chairman

and Chairman of the Board of Rafael Holdings.

About Rafael Holdings, Inc.

Rafael Holdings, Inc. is a biotechnology company

that develops pharmaceuticals and holds interests in clinical and early-stage companies that develop pharmaceuticals and medical devices.

Our lead candidate is Trappsol® Cyclo, which is being evaluated in clinical trials for the potential treatment of NPC a

rare, fatal and progressive genetic disorder. We also hold interests in other clinical-stage and early-stage pharmaceutical development

companies and an orthopedic-focused medical device company.

Forward Looking Statements

This press release contains forward-looking statements

within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not

relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding

our expectations surrounding the potential, safety, efficacy, and regulatory and clinical progress of our product candidates; plans regarding

the further evaluation of clinical data; and the potential of our pipeline, including our internal cancer metabolism research programs.

These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that

may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements

expressed or implied by the forward-looking statements, including, but not limited to, those disclosed under the caption “Risk Factors”

in our Annual Report on Form 10-K for the year ended July 31, 2025, and our other filings with the SEC. These factors could cause actual

results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking

statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking

statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

Contact:

Barbara Ryan

Barbara.ryan@rafaelholdings.com

(203) 274-2825

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